Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT02077257
Eligibility Criteria:
Inclusion Criteria:
* 18-80 year old males and non-child-bearing period females.
* Clinical diagnosed with acute coronary syndrome including NSTE-ACS ,MI and STEMI.
* Patients with STEMI((ST segment elevation myocardial infarction) and NSTEMI(non-ST segment elevation myocardial infarction) will be recruited within 48 hours of symptom onset.
* The LDL-C≥70mg/dL one week before randomization.
* The TG\<500mg/dL one week before randomization.
* No cholesterol-lowering drugs (including lipid lowering dietary supplements, antioxidants, or food additives) during 4 weeks before randomization.
* Sign the ICF(inform consent form)
Exclusion Criteria:
* Acute pulmonary edema, severe congestive heart failure,
* acute moderate mitral regurgitation, acute ventricular septal perforation,
* severe arrhythmia (ventricular fibrillation, sustained ventricular tachycardia, complete heart block), sepsis, acute pericarditis,
* any evidence of systemic or pulmonary embolus within the preceding 4 weeks.
* Coronary artery bypass graft within the preceding 3 months; percutaneous coronary intervention within the preceding 6 months.
* A history of hypersensitivity of statins and other severe complication.
* child-bearing women
* hypothyroidism,
* active liver disease or dysfunction including agnogenic serum transaminase sustained elevation or higher than 3 times ULN(upper limit of normal)
* severe anemia (hemoglobin,hematocrit \< 28%),
* Patients with myopathy or serum creatine kinase \> 3 times the upper limit of normal not caused by myocardial injury.
* A history of psychiatric disorders
* A history of jejunoileal bypass or gastric bypass surgery
* Currently take steroids therapy
* Currently take phenytoin sodium,phenobarbital,carbamazepine (which may primary efficacy endpoint)
* Diagnosed with malignant within 5 years
* Severe renal function damage (creatinine clearance rate\<30 ml/min)
* Concurrent use ciclosporin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02077257
Study Brief:
Protocol Section:
NCT02077257